Table 2.
Treatment‐emergent adverse events occurring in ≥5% of participants
| Placebo, n = 10 | PRX002 | All PRX002 doses, n = 30 | |||||
|---|---|---|---|---|---|---|---|
| 0.3 mg/kg, n = 6 | 1 mg/kg, n = 6 | 3 mg/kg, n = 6 | 10 mg/kg, n = 6 | 30 mg/kg, n = 6 | |||
| Adverse events, n (%) | 5 (50.0) | 1 (16.7) | 1 (16.7) | 3 (50.0) | 4 (66.7) | 4 (66.7) | 13 (43.3) |
| Treatment‐related adverse events, n (%) | 1 (10.0) | – | 1 (16.7) | – | 3 (50.0) | – | 4 (13.3) |
| Treatment‐emergent adverse events, n (%) | |||||||
| Vessel puncture site pain | 1 (10.0) | – | – | – | 1 (16.7) | 1 (16.7) | 2 (6.7) |
| Headache | 1 (10.0)a | – | – | 1 (16.7) | 1 (16.7)a | – | 2 (6.7) |
| Viral infection | 1 (10.0) | 1 (16.7) | – | – | 1 (16.7) | – | 2 (6.7) |
| Nausea | – | – | – | – | 2 (33.3)a | – | 2 (6.7) |
| Neutropenia | – | 1 (16.7) | – | – | 1 (16.7)b | – | 2 (6.7) |
| Upper respiratory infection | – | – | – | – | 1 (16.7) | 1 (16.7) | 2 (6.7) |
| Pruritus | 1 (10.0) | – | – | – | 1 (16.7) | – | 1 (3.3) |
Unless indicated, all adverse events were mild and unrelated to study drug.
a
Considered related to study drug.
b
Severe adverse event of neutropenia was reported and was determined by the investigator to be viral in origin and unrelated to study drug.